Product Engineer/Designer Medical Device

Apr 06, 2012
May 06, 2012
Job Type
Employment Status
Full Time

Qualified candidates may send their resume to for immediate consideration.

The Product Engineer/Designer position is responsible for:

  • Developing product concepts following procedures per ISO and FDA utilizing processes.  Coordinating the Product Development team to support any new/re-design products.
  • Prepare/Review drawings for engineering, production and quality control as requested
  • Define Manufacturing protocols
  • Assist with Quality control of products before shipping and assist with quality related issues and be involved on resolution team
  • Maintain drawings within the Device Master Record
  • Create formal process documentation such as Work Instructions Inspection Procedures Manufacturing Procedures.


Job Skills/Requirements  
Minimum of 4 year technical degree (BS/ME preferred) or similar work experience required.

  •  Knowledge of manufacturing assembly ,QA, manufacturing environments including plastics, metals materials preferred.
  • Knowledge of DOE, FMEA and Risk Management  process preferred
  • 5+ years work experience as a Product Designer utilizing Design Control Procedures with Medical Devices (ISO 13485 or ISO 9001 certified company)
  • 5+ years experience on Product Development teams with Medical Device Required


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